Patient interactive neurostimulation system and method Number:7,386,348 from the United States Patent and Trademark Office (PTO) owispatent A fully automated computer controlled system is provided for adjustment of neurostimulation implants used in pain therapy and in treating neurological dysfunction which includes a patient interactive computer, and a universal transmitter interface integrally embedded in the patient interactive computer or built into the antenna which is capable of stimulating any type of implanted neurostimulation devices by imitating programming codes. The patient interacts with the system through the patient interactive computer. The universal transmitter interface includes a direct digital synthesizer, a transistor circuitry driving the antenna in ON-OFF fashion and a gating unit for driving the transistor circuitry under control of the processing means in the patient-interactive computer. Alternatively, the universal transmitting interface includes a balanced modulator for modulation of the carrier signal generated at the direct digital synthesizer.<H neurostimulation, interactive, Patient, interac, 7386348.html, Patent, pto, 7386348

Title: Patient interactive neurostimulation system and method

Abstract: A fully automated computer controlled system is provided for adjustment of neurostimulation implants used in pain therapy and in treating neurological dysfunction which includes a patient interactive computer, and a universal transmitter interface integrally embedded in the patient interactive computer or built into the antenna which is capable of stimulating any type of implanted neurostimulation devices by imitating programming codes. The patient interacts with the system through the patient interactive computer. The universal transmitter interface includes a direct digital synthesizer, a transistor circuitry driving the antenna in ON-OFF fashion and a gating unit for driving the transistor circuitry under control of the processing means in the patient-interactive computer. Alternatively, the universal transmitting interface includes a balanced modulator for modulation of the carrier signal generated at the direct digital synthesizer.

Patent Number: 7,386,348 Issued on 06/10/2008 to North, et al.

Inventors: North; Richard Boydston (Baltimore, MD), Sieracki; Jeffrey Mark (Silver Spring, MD), Fowler; Kim Randal (Baltimore, MD), Holland; Lon Hodges (Olney, MD)
Assignee: Medtronic, Inc. (Minneapolis, MN)

Appl. No.: 10/669,392

Filed: September 24, 2003

Related U.S. Patent Documents


Application Number	Filing Date	Patent Number	Issue Date
09732759	Dec., 2000	6654642
09408129	Sep., 1999	6308102

Current U.S. Class: 607/46

Field of Search: 607/46,48,55-57

References Cited [Referenced By]

U.S. Patent Documents


4520825	June 1985	Thompson et al.
4735204	April 1988	Sussman et al.
4784142	November 1988	Liss et al.
4803988	February 1989	Thomson
4813418	March 1989	Harris
4958632	September 1990	Duggan
4977895	December 1990	Tannenbaum
5002053	March 1991	Garcia-Rill et al.
5014705	May 1991	Graupe et al.
5033469	July 1991	Brodard
5052391	October 1991	Silberstone et al.
5081989	January 1992	Graupe et al.
5092329	March 1992	Graupe et al.
5117826	June 1992	Bartelt et al.
5143089	September 1992	Alt
5159926	November 1992	Ljungstroem
5215086	June 1993	Terry, Jr. et al.
5314458	May 1994	Najafi et al.
5330515	July 1994	Rutecki et al.
5335657	August 1994	Terry, Jr. et al.
5350414	September 1994	Kolen
5354320	October 1994	Schaldach et al.
5370672	December 1994	Fowler et al.
5387231	February 1995	Sporer
5417719	May 1995	Hull et al.
5423877	June 1995	Mackey
5443486	August 1995	Hrdlicka et al.
5458625	October 1995	Kendall
5458626	October 1995	Krause
5466246	November 1995	Silvian
5540730	July 1996	Terry, Jr. et al.
5569166	October 1996	Stone
5643329	July 1997	Solomonow et al.
5643330	July 1997	Holsheimer et al.
5653739	August 1997	Maurer et al.
5702429	December 1997	King
5716377	February 1998	Rise et al.
5725564	March 1998	Freed et al.
5755736	May 1998	Gillberg et al.
5807397	September 1998	Barreras
5843139	December 1998	Goedeke et al.
5843142	December 1998	Sultan
5893883	April 1999	Torgerson et al.
5938690	August 1999	Law et al.
6175764	January 2001	Loeb et al.
6205359	March 2001	Boveja
6249703	June 2001	Stanton et al.
6308100	October 2001	Er et al.
6308102	October 2001	Sieracki et al.
6321117	November 2001	Koshiol et al.
6381496	April 2002	Meadows et al.
6440090	August 2002	Schallhorn
6516227	February 2003	Meadows et al.
6564807	May 2003	Schulman et al.
2002/0116036	August 2002	Daignault, Jr. et al.
2003/0028223	February 2003	Olson

Foreign Patent Documents


WO 97/43002	Nov., 1997	WO
WO 98/29160	Jul., 1998	WO

Other References

Robin et al., "A New Implantable Microstimulator Dedicated to Selective Stimulation of the Bladder," Proceedings--19.sup.th International Conference--IEEE/EMBS Oct. 30-Nov. 2, 1997, Chicago, IL, pp. 1792-1795. cited by other .
North et al., "Spinal cord stimulation for chronic intractable pain," Spinal Cord Stimulation II, pp. 49-63, Darmstadt, Steinkopff, 1995. cited by other .
North et al., "Artificial Neural Networks: Application to Electrical Stimulation of the Nervous System," (abstract) Stereotactic and Functional Neurosurgery 65:161, 1995. cited by other .
North et al., "Artificial Neural Networks: application to electrical stimulation of the human nervous system," Neurosurgical Focus 2(1:):1-5, 1997. cited by other .
North et al., "Patient-Interactive, Microprocessor-Controlled Neurological Stimulation System," Neuromodulation 1(4):185-193, 1998. cited by other .
Fowler, K.R., "Neurological Stimulation System", Proceedings AAMI 21.sup.st Annual Meeting, Apr. 12-16, 1986, p. 27. cited by other .
North et al., "Spinal Cord Stimulation for Chronic, Intractable Pain: Experience over Two Decades Clinical Study," Neurosurgery, vol. 32, No. 3, 1993, pp. 384-395. cited by other .
North et al., "Spinal cord stimulation for chronic, intractable pain: superiority of `multi-channel` devices," Pain, vol. 44, 1991, pp.119-130. cited by other .
North et al., "Spinal Cord Stimulation for Chronic Pain," Functional Neurosurgery, vol. 6, No. 1, Jan. 1995, pp. 145-155. cited by other .
North, R.B., "Spinal Cord Stimulation for Chronic, Intractable Pain," Electrical and Magnetic Stimulation of the Brain and Spinal Cord, 1993, pp. 289-301. cited by other .
North, R.B., "The Role of Spinal Cord Stimulation in Contemporary Pain Management," APS Journal, vol. 2, No. 2, 1993, pp. 91-99. cited by other .
Alo et al., "Computer Assisted and Patient Interactive Programming of Dual Octrode Spinal Cord Stimulation in the Treatment of Chronic Pain," Neuromodulation, vol. 1, No. 1, 1998, pp. 30-45. cited by other .
Fowler et al., "Patient-interactive PC interface to implanted, multichannel stimulators," Proceedings of 39.sup.th Annual Conference on Engineering in Medicine and Biology, p. 380, 1986. cited by other .
North et al., "Computer-Controlled, Patient-Interactive, Multichannel, Implanted Neurological Stimulators," Applied Neurophysiology 50:39-41, 1987. cited by other .
North et al., Computer-controlled, multichannel, implanted neurological stimulation system: clinical assessment, Pain (Suppl.) 5:S83, 1990. cited by other .
Fowler et al., "Computer-Optimized Neurological Stimulation," Proc. Ann. Internat. Conf. IEEE Engineering Medicine and Biology Soc., vol. 13, No. 4, pp. 1692-1693, 1991. cited by other .
Fowler et al., "Computer-Optimized Neurostimulation," APL Technical Digest, vol. 12, No. 2, pp. 192-197, 1991. cited by other .
North et al., "Patient-interactive, computer-controlled neurological stimulation system: clinical efficacy in spinal cord stimulator adjustment." Journal of Neurosurgery 76:967-972, 1992. cited by other .
North et al., "Automated `pain drawing` analysis by computer-controlled, patient-interactive neurological stimulation system," Pain 50:51-57, 1992. cited by other .
North et al., "Computer-controlled, patient-interactive neurological stimulation system," (Abstract) Acta Neurochir 117:90, 1992. cited by other .
North et al., "Patient-Interactive, Microprocessor-Controlled Neurological Stimulation System," (Abstract), Stereotactic and Functional Neurosurgery 62:309-315, 1994. cited by other .
North et al., "Consensus Conference on the Neurosurgical Management of Pain," Neurosurgery 34:4, 756-761, 1994. cited by other .
North et al., "A Prospective, Randomized Study of Spinal Cord Stimulation versus Reoperation for Failed Back Surgery Syndrome: Initial Results," Stereotact Funct Neurosurg 1994:62:267-272. cited by other .
North et al., "Prognostic Value of Psychological Testing in Patients Undergoing Spinal Cord Stimulation: A Prospective Study," Neurosurgery, vol. 39, No. 2, 1996. cited by other .
North et al., "Specificity of diagnostic nerve blocks: a prospective, randomized study of sciatica due to lumbosacral spin disease," Pain, 65, pp. 77-85, 1996. cited by other .
North et al., "Automated, Patient-Interactive, Spinal Cord Stimulator Adjustment: A Randomized Controlled Trial," Neurosurgery 52:572-580, 2003. cited by other .
Khalessi et al., "Automated, patient-interactive spinal cord stimulator adjustment: A cost-minimization analysis," Neurosurgery, vol. 53, No. 2, pp. 501-502, 2003. cited by other .
"GenesisXP.TM. Neurostimulation Systems," Implantable Therapies for Chronic Pain and Neurological Disorders, http://www.ans-medical.com/physicians/GenesisXPSystem/XPOverview.cfm (2 pgs.) downloaded Dec. 3, 2002. cited by other .
"PainDoc.RTM. Computerized Support System," Implantable Therapies for Chronic Pain and Neurological Disorders, http://www.ans-medical.com/physicians/PainDoc/PainDoc.html (1 pg.) downloaded Dec. 3, 2002. cited by other .
"MultiStim.RTM.," Implantable Therapies for Chronic Pain and Neurological Disorders, http://www.ans-medical.com/physicians/RenewRFSystem/MultiStim.html (2 pgs.) downloaded Dec. 3, 2002. cited by other .
"PC-Stim.RTM.," Implantable Therapies for Chronic Pain and Neurological Disorders, http://www.ans-medical.com/physicians/RenewRFSystem/PCStim.html (2 pgs.) downloaded Dec. 3, 2002. cited by other .
"Renew.RTM. Neurostimulation System Overview," Implantable Therapies for Chronic Pain and Neurological Disorders, http://www.ans-medical.com/physicians/RenewRFSystem/SystemOverview.html (3 pgs.) downloaded Dec. 3, 2002. cited by other.

Primary Examiner: Evanisko; George R.
Attorney, Agent or Firm: Shumaker & Sieffert, PA

Parent Case Text

This Patent Application is a continuation of U.S. application Ser. No. 09/732,759, filed Dec. 11, 2000, now U.S. Pat. No. 6,654,642, which is a continuation-in-part of U.S. application Ser. No. 09/408,129, filed Sep. 29, 1999. now U.S. Pat. No. 6,308,102. The entire content of each of the identified U.S. Applications is incorporated herein by reference.

Claims

What is claimed is:

1. A method comprising: controlling an implantable neurostimulator to deliver neurostimulation to a patient according to a plurality of stimulation settings during a programming session; displaying a list of the stimulation settings; collecting information for each of the stimulation settings, wherein the collected information comprises: rating information comprising: a numeric rating for the stimulation setting; and a degree of overlap between a paresthesia map for the stimulation setting and a pain map; and a threshold amplitude value for the stimulation setting; receiving input from a user choosing at least one criteria selected from the collected information; and ordering the list according to the at least one user-chosen criteria selected from the collected information.

2. The method of claim 1, wherein each of the stimulation settings includes a pulse width, a pulse frequency, an identification of activated electrodes, and an identification of polarities of activated electrodes.

3. The method of claim 1, wherein the user-chosen criteria comprises the numeric ratings, and ordering the list comprises ordering the list according to the numeric ratings.

4. The method of claim 1, wherein the numeric ratings indicate a degree of pain-relief.

5. The method of claim 1, wherein the user-chosen criteria comprises tho degrees of overlap and ordering the list comprises ordering the list according to the degrees of overlap.

6. The method of claim 1, wherein collecting rating information comprises collecting rating information from the patient.

7. The method of claim 1, further comprising selecting at least one stimulation setting from the plurality for retesting based on the user-chosen criteria.

8. The method of claim 1, further comprising automatically programming the neurostimulator with at least one of the stimulation settings based on the user-chosen criteria.

9. The method of claim 1, wherein controlling the implantable neurostimulator to deliver neurostimulation to the patient according to the plurality of stimulation settings during the programming session comprises: storing a plurality of predetermined programming codes; identifying a type of an implantable neurostimulator; selecting one of the plurality of programming codes based on the identified type; and transmitting the selected programming code to the implantable neurostimulator to enable programming of the implantable neurostimulator.

10. The method of claim 9, wherein transmitting the selected programming code comprises modulating a carrier signal.

11. The method of claim 10, further comprising retrieving parameters for modulation of the carrier signal from a memory based on the identified type of the implantable neurostimulator.

12. The method of claim 1, further comprising receiving input from the patient indicative of a stimulation amplitude of the neurostimulation, wherein controlling the implantable neurostimulator to deliver neurostimulation to the patient comprises controlling the implantable neurostimulator to deliver neurostimulation to the patient at the stimulation amplitude indicated by the user.

13. The method of claim 1, further comprising determining the threshold amplitude value for each of the stimulation settings.

14. The method of claim 1, wherein collecting the threshold amplitude value for each of the stimulation settings comprises determining at least one of a perceptual threshold, a usage threshold, an area of interest threshold, a motor threshold or a discomfort threshold for each of the stimulation settings.

15. The method of claim 1, further comprising, for each stimulation setting, determining whether the rating information falls within boundaries based on the threshold amplitude value.

16. The method of claim 1, further comprising: providing the collected information to at least one of a server or a database.

17. A device for programming an implantable neurostimulator comprising a display, wherein the device is adapted to control the implantable neurostimulator to deliver neurostimulation to a patient according to a plurality of stimulation settings during a programming session, display a list of the stimulation settings via the display, collect information for each of the stimulation settings, receive input from a user choosing at least one criteria selected from the collected information, and order the list according to the at least one user-chosen criteria, wherein the collected information comprises: rating information comprising: a numeric rating for each of the stimulation settings; and a degree of overlap between a paresthesia map for the stimulation setting and a pain map; and a threshold amplitude value for the stimulation setting.

18. The device of claim 17, wherein each of the stimulation settings includes a pulse width, a pulse frequency, an identification of activated electrodes, and an identification of polarities of activated electrodes.

19. The device of claim 17, wherein the user-chosen criteria comprises the numeric ratings, and the device orders the list according to the numeric ratings.

20. The device of claim 17, wherein the numeric rating indicates a degree of pain-relief.

21. The device of claim 17, wherein the display is a touch screen display, and the device collects the numeric rating via the display.

22. The device of claim 17, wherein the display is a touch screen display, and wherein the user-chosen criteria comprises the degrees of overlap, and the device orders the list according to the degrees of overlap.

23. The device of claim 17, wherein the device selects at least one stimulation setting from the plurality for retesting based on the user-chosen criteria.

24. The device of claim 17, wherein the device is adapted to automatically program the neurostimulator with at least one of the stimulation settings based on the user-chosen criteria.

25. The device of claim 17, wherein the device comprises a portable computer.

26. The device of claim 17, wherein the device comprises a tablet computer.

27. The device of claim 17, wherein the device further comprises: an antenna that identifies a type of the implantable neurostimulator; and a transmitter interface that includes a memory to store a plurality of predetermined programming codes, wherein the transmitter interface is adapted to receive an indication of the identified type of the implantable neurostimulator, select one of the plurality of programming codes based on the identified type, and transmit the selected programming code to the implantable neurostimulator via the antenna to enable programming of the implantable neurostimulator to deliver neurostimulation to the patient.

28. The device of claim 27, wherein the transmitter interface transmits the selected programming code by modulating a carrier wave.

29. The device of claim 28, wherein the memory stores parameters for modulation of the carrier wave associated with each of the programming codes, and the transmitter interface further includes control interface circuitry that retrieves parameters from the memory based on the identified type of the implantable neurostimulator and controls modulation of the carrier wave according to the retrieved parameters.

30. The device of claim 28, wherein the transmitter interface includes at least one of a direct digital synthesizer, programmable gain/amplitude circuitry or a transistor circuit to modulate the carrier wave.

31. The device of claim 17, wherein the device presents an amplitude adjustment screen and receives input from the user adjusting a stimulation amplitude of the neurostimulation via the amplitude adjustment screen.

32. The device of claim 17, wherein the device determines the threshold amplitude value for each of the stimulation settings.

33. The device of claim 17, wherein the device provides the collected information to at least one of a server or a database.

34. A system for programming an implantable neurostimulator comprising: means for controlling the implantable neurostimulator to deliver neurostimulation to a patient according to a plurality of stimulation settings during a programming session; means for displaying a list of the stimulation settings; means for collecting information for each of the stimulation settings, wherein the collected information comprises: rating information comprising: a numeric rating for the stimulation setting; and a degree of overlap between a paresthesia map for the stimulation setting and a pain map; a threshold amplitude value for the stimulation setting; and means for receiving input from a user choosing at least one criteria from the collected information; and means for ordering the list according to a least one user-chosen criteria selected from the collected information.

35. The system of claim 34, wherein the user-chosen criteria comprises the rating information, and the means for ordering the list comprises means for ordering the list according to the numeric ratings.

36. The system of claim 34, wherein the user-chosen criteria comprises the degrees of overlap, and the means for ordering the list comprises means for ordering the list according to the degrees of overlap.

37. The system of claim 34, further comprising means for selecting at least one stimulation setting from the plurality for retesting based on the user-chosen criteria.

38. The system of claim 34, further comprising means for automatically programming the neurostimulator with at least one of the stimulation settings based on the user-chosen criteria.

39. The system of claim 34, further comprising means for providing the collected information to at least one of a server or a database.

Description

FIELD OF THE INVENTION

The present invention relates to a fully automated patient interactive system for controlling neurostimulation, and more particularly, to a computer controlled system for automatic adjustment of neurostimulation implants used in pain therapy and in treating neurological dysfunction capable of automatically handling inconsistent patient data entries and unexpected conditions such as hardware failures.

Even more particularly, the present invention relates to a patient interactive system operated directly by the patient who may be safely and confidently left alone to work with the computer to obtain reliable data with the goal of maximizing pain relief while minimizing staff time demand. The novel system essentially replaces the physician, or physician's assistant, in the routine and tedious task of adjusting stimulation settings for the neurostimulation procedure.

Moreover, the present invention relates to a patient interactive system comprising a patient interactive pentop tablet computer which may include an RF (radio frequency) interface device integrally built in the pentop tablet computer or in the antenna in combination with patient interactive software and allows signal communication with neurostimulation implants using radio frequency telemetry.

Additionally, the present invention relates to a patient interactive system for controlling neurostimulation which includes a unified user interface in which the body outlines and the patient's drawings are input directly to the computer screen.

The present invention further relates to a patient interactive system having a "universal" transmitter for controlling implantable devices capable of imitating unique codes generated by proprietary neurostimulation systems thereby allowing the system of the present invention to work with a wide variety of implantable devices.

The present invention also relates to a method of controlling the neurostimulation in a neurological stimulation system for collecting data from a patient through a series of steps and further processing the collected data for optimization of the stimulus setting for the most effective pain relief and treatment.

PRIOR ART

Neurostimulators treat chronic pain by stimulating nerves, such as those of the spinal cord, with electrical pulses. Typically, neurostimulator systems comprise an external device which communicates with an implantable device through electromagnetic transmissions. The external device acts as a programmer for the implanted device by means of transmitting radio frequency codes to the implanted device to program its operation.

Neurostimulators have a number of parameters and adjustments that optimize the stimulation for each individual situation. Electrodes have multiple contacts that can have positive, negative, or off-polarity. Common configurations have 4, 8, or 16 electrode contacts within the stimulating bundle. Four electrodes can have 50 separate usable combinations of polarities. Eight electrodes can have 6050 separate usable combinations of polarities. Sixteen electrodes can have over 62,000,000 separate usable combinations of polarities. Beyond this, neurostimulators can set the frequency of stimulation between 1 Hz and 1500 Hz, set the pulse widths of stimulation between 10 and 1000 microseconds, and vary the amplitude of stimulation. These nearly inexhaustible adjustments quickly overwhelm the physical capabilities of medical staff to adjust stimulators through all settings for each patient.

To help with this concern, a computer-controlled neurological stimulation system, U.S. Pat. No. 5,370,672, was developed. The system provides efficient patient interaction, optimizes stimulation automatically, and delivers arbitrary and unique paradigms of stimulation. As shown in FIG. 1, an external transmitter 10 and implanted receiver 11 are RF coupled by an antenna 12. The external transmitter 10 is worn externally by the patient 13 to encode the stimulation parameters and the electrode selections, which are then transmitted to the implanted receiver 11 via the antenna 12. The implant decodes the transmitted information and generates the desired electrical pulses for stimulating electrodes 14 within the spinal column 15.

As shown in FIG. 2, the computer-controlled neurological stimulation system of the '672 patent includes a host computer 16, an interface enclosure 17 coupled by a cable 18 to the host computer 16, with an output line 19 coupled to an antenna 20. A graphic tablet 21 is connected by a serial line 22 to the host computer 16 which permits entry to the host computer 16 of the location of stimulation paresthesias and painful areas when a stylus 23 is manipulated over the tablet 21 by the patient. The tablet 21 has an overlay positioned on the top of the tablet 21 and contours of the body are drawn on the overlay. In operation, the physician initiates a session with the patient by calling up the appropriate programs in the host computer 16. The host computer 16 and interface enclosure 17 control one of several selective transmitters and cause the generation of various stimulation parameters such as frequency, pulse amplitude, width, and electrode combination. The patient at this time is directed via the graphics tablet 21 to interact with the host computer 16 and the interface enclosure 17 to adjust the stimulation amplitude as necessary and to sketch on the tablet 21 the areas of pain and the areas perceived by the patient to be experiencing paresthesias. While useful in reducing the workload of medical staff and automating the data collection, the system still has a number of limitations which include: 1. The patient has to look up to the monitor of the host computer 16 for instructions and then down at the graphics tablet 21 to draw responses and answers which presents a challenge in hand-eye coordination and slows data collection. 2. The overlay on the graphics tablet needs careful adjustment to accurately match its outlines of the body with the host computer's internal representation of those outlines. This calibration is also necessary to match the drawings made by the patient which represent areas of pain and stimulation paresthesia with the host computer's internal representation of the body. 3. The serial communications cable 18 between the host computer 16 and the transmitter enclosure 17 is prone to mechanical as well as electrical failure. 4. The patient is in physical contact with the transmitter interface enclosure 17 and the host computer 16, both of which are connected to electrical cords and wall outlets. These devices are powered by the building's AC power and consequently have a grounded connection that can provide a leakage path or short circuit to ground.

Another patient interactive computer based neurostimulation system is described in U.S. Pat. No. 5,938,690. This system can assist in the performance of pre-, intra-, and post-operative procedures relating to the determination and optimization of a patient's therapeutic regimen. The system is intended to record and process patient's responses to test stimulation patterns during the operation of placing the electrodes, so as to give the physician real-time information that can be used to effectively position the electrodes within the patient's body. The system also provides computer assisted post-operative presentation and assessment of stimulation settings.

Disadvantageously, the systems of prior art are not truly automated and require frequent attention by clinical staff during operation because either they do not provide automated patient interviews or their unsophisticated interview schemes are unable to automatically handle inconsistent patient data entries and unexpected conditions such as hardware failures.

Another shortcoming of the prior art neurostimulation systems is that each manufacturer of implanted devices generally has proprietary codes built on combinations of the modulation techniques to program the implantable devices. Consequently, each manufacturer has proprietary hardware, software, and systems to transmit the programming code. If a separate external system other than one provided by a manufacturer of implantable devices, communicates with an implantable device, the external system requires circuitry that emulates the proprietary system. Should the external system communicate with multiple different types of implantable devices, it must include separate circuitry to emulate each type of implant. As an example, in the system described in U.S. Pat. No. 5,938,690, a physician enters into the computer information related to electrode type and transmitter type. Thus, the system requires the transmitter to "learn" certain stored information, ensuring that the transmitter, electrodes and the system in its entirety are compatible. In each operation, the transmitter must be reset with respect to electrodes it is supposed to work with, and the transmitter may have to be replaced with another type if the adaptation is not possible due to incompatibility of the electrodes and the transmitter.

It is therefore clear that despite the advances and improvements in prior art systems for controlling neurostimulators, a novel system which is automated and "universal", i.e., compatible with a wide variety of different types of implantable devices is needed in the art of neurostimulation.

SUMMARY OF THE INVENTION

It is therefore an object of the present invention to provide a truly automated patient interactive system in which provisions are made allowing for effectively handling inconsistent patient data entries, if any, and unexpected conditions such as hardware failures, thus providing that the patient may be safely and confidently left alone to work with the computer and where reliable data can be attained without significant intervention by a human clinician during the procedure.

It is another object of the present invention to provide a patient interactive system having a "universal transmitter" adaptable substantially to all types of implanted devices, including both RF-powered and implantable pulse generators (IPG) with self-contained power sources.

It is a further object of the present invention to provide a patient interactive system for controlling neurostimulation, in which the body outline, instructions for the patient, and the patient's response are displayed and drawn on the same screen of the patient interface computer, thus avoiding hand-eye coordination problems.

It is another object of the present invention to provide a patient interactive system where the drawings are made by the patient directly on the computer screen, thereby making the data collection easier to use and speedier to collect.

It is still another object of the present invention to provide a patient interactive system having a unified structure which eliminates cables between various components, thereby greatly reducing possible-mechanical and electrical failure.

It is still a further object of the present invention to provide a patient interactive system employing a battery-powered pen top computer thereby eliminating leakage paths and short circuits to ground.

It is yet another object of the present invention to provide a patient interactive system, a method for controlling neurostimulation, and software stored in the patient interactive computer to operate the system for data collection, data processing, and optimization of stimulation settings for a particular patient and his/her problem.

In accordance with the present invention, a patient interactive system for controlling neurostimulation includes a plurality of neurological stimulator devices implanted in the body of a patient, a patient interactive computer with a display, a transmitter interface unit integrally embedded within the patient interactive computer or built-in the antenna, a stylus movable by the patient in response to the request displayed on the display of the patient interactive computer, a physician's desktop computer telemetrically communicating with the patient interactive computer, and operational software to run the system.

It is an essential and novel feature of the present invention that means are provided in the system which pre-sets consistency boundaries for data entered by the patient and which verify that the entered data fall within the consistency boundaries. If the consistency boundaries are exceeded, then the data entered are recycled, and the patient is asked to repeat a response, or the system is checked for hardware failure. This arrangement in the system of the present invention provides for full automation of operation, obtaining of reliable data, and safety for the patient, so that he/she may be confidently left alone to work with the system without intervention by a clinician.

It is also important that the system of the present invention is capable of studying the consistency behavior of the patient, and, if satisfactory, to avoid verification as to whether the boundaries are exceeded, thus providing for adaptation to each particular patient.

The neurological stimulator devices are adapted for receiving a specific one of a plurality of predetermined programming codes and responding to this code to provide electrical stimulation to nerve tissue in accordance with the programming code. It is essential that the transmitter interface unit embedded within the patient interactive computer or the antenna unit includes controlling means which are adapted to imitate any one of a plurality of predetermined programming codes and drive the transmitter interface unit to transmit the imitated specific predetermined code toward the neurological stimulator device thus providing for universality of the transmitter.

The system includes graphic means displaying screen graphics and screen worded messages for the patient (the message corresponding to the screen graphics) substantially simultaneously on the display of the patient interactive computer. The screen worded message describes to the patient an action expected from the same to operate the stylus in order to enter requested data into the patient interactive computer.

The screen graphics may present images of a human's body. Subsequently, the screen worded message requests the patient to outline, by means of the stylus, an area of the pain being experienced. The screen worded message may also request the patient to outline, by means of the stylus, a topography of paresthesias in response to electrical stimulation of the neurological stimulator devices by the specific predetermined programming code transmitted from the transmitter interface. The interior regions of graphical outlines may later be compared by the computer as part of the analysis to determine preferred stimulation settings. It is essential that the pain map and the topography of paresthesias are compared pixel by pixel rather than by any standard dermatomes in order to adapt the analysis accurately to the individual patient.

The screen graphics may also present a rating bar. The screen worded message constitutes a request for the patient to indicate on the rating bar (by means of the stylus) the degree of overlap of the area of the pain experienced and the topography of paresthesias.

Alternatively, the screen graphics may present a stimulation amplitude adjustment screen for threshold determination which includes an amplitude adjustment bar. In this mode the screen worded message requests the patient to increase the amplitude by sliding the stylus along the amplitude adjustment bar until the patient begins to feel a sensation that meets the stated criteria.

The system is capable of determination of a plurality of stimulation thresholds including the bilateral threshold, discomfort threshold, perceptual threshold, preferred level of pain relief threshold, area of interest threshold, and motor threshold. These parameters are further processed for obtaining an optimized stimulation setting for-a particular patient and his/her problem.

Briefly, the present invention is directed to a computer controlled system for fully automatic adjustment of a neurostimulation implant used in pain therapy and in treating neurological dysfunctions. The system as herein described has been found to fill a void in modern healthcare technology. The system's unique features dramatically decrease physician workload, increase productivity and increase efficiency of neurostimulators. The system is operated directly by the patient and substantially replaces the physician in the routine and tedious task of adjusting stimulation settings. The physician needs only to connect the patient to a patient interactive computer and select a protocol either on the physician's desktop computer or on the patient interactive computer 25. Thorough records are compiled during adjustment sessions and this data along with the optimum setting analysis results are available for post session review by a clinician.

The patient interactive computer is preferably a pentop tablet computer often including a transmitter interface which allows it to communicate with neurostimulation implants using radio frequency telemetry. (In the alternative, the transmitter interface may be embedded in the antenna.) The patient interactive computer and/or the physician's computer contain patient interactive software that has evolved out of extended periods of clinical research. The system may communicate using an infrared link with a printer for generating hard copy reports or with a desktop PC in the physician's office for providing patient data. The patient interactive computer also may communicate with a remote computer server through a telephone line, to obtain value added services or software updates.

The transmitter interface includes: a control interface unit communicating with the patient interactive computer to transmit data defining which one of a plurality of the predetermined programming codes has to be generated within the transmitter interface unit; a data memory unit adapted to store a plurality of parameters for the multiplicity of specific predetermined programming codes; a direct digital synthesizer interfacing with the control interface unit and receiving data from it; a programmable clock unit interfacing with the control interface unit and receiving data therefrom for clocking the direct digital synthesizer; a programmable gain/amplitude control unit interfacing with the control interface unit and receiving data from it; and a radio frequency amplifier coupled to an output of the direct digital synthesizer and amplifying an output signal received therefrom to be transmitted to the neurological stimulator device.

An alternative embodiment to the use of a radio frequency amplifier which in certain instances may not be an efficient method of driving the antenna, an alternative approach is taken for the transmitter interface unit. In the alternative embodiment, the transmitter interface unit comprises a control interface unit communicating with the patient interactive computer to interchange the data defined by the processing means of the patient interactive computer. A data memory system is adapted to store a plurality of parameters for the proprietary programming codes. Further a direct digital synthesizer (DDS) interfacing with the control interface unit for receiving data therefrom and outputting a carrier signal in response thereto is provided. A transistor circuitry is operatively coupled to the antenna for driving the antenna in on/off fashion. Finally a driving unit interfacing with the direct digital synthesizer is provided for generating gating pulses supplied to the transistor circuitry to drive such in a manner defined by the processing means within the patient interactive computer.

The driving unit may include either an analog comparator receiving at one input thereof the carrier signal (in analog form) from the DDS and comparing the carrier signal with a reference signal supplied to another input of the analog comparator. Alternatively, the driving unit includes a digital comparator receiving at one input thereof a carrier signal (in digital form) from the DDS and comparing the carrier signal to a reference code which is indicative of the width of a gating pulse to be output from the comparator. The output of the comparator (either digital or analog) is coupled to the transistor circuitry which in turn, drives the antenna.

Preferably, the transistor circuitry is an H-bridge which may include multiple inputs independently driven by the driving unit. Several implementations of the H-bridge circuit are contemplated in the scope of the present invention. In order to drive inputs of the H-bridge circuit independently, either multiple comparators are employed in the universal transmitter, or a single comparator with multiple outputs is used to supply gating control signals to the respective inputs of the H-bridge circuit.

In another alternative embodiment, the universal transmitter interface unit includes a balanced modulator for modulating the carrier signal. In this implementation, a combination of analog and digital techniques is used to provide a flexible and versatile modulation of the carrier signal generated at the digital direct synthesizer. In this embodiment, the transmitter interface unit further includes a low pass filter coupled between the output of the digital-to-analog converter (DAC) of the direct digital synthesizer and a first input of the modulator unit. A digital comparator having first and second inputs and coupled by the first input thereof to the output of the phase accumulator of the direct digital synthesizer and by the second input thereof to the control interface unit is included. A switching mechanism is incorporated for intermittently connecting a second input of the modulator unit to the output of the digital comparator and an output of the control interface unit.

In operation, a physician enters information about a patient into the system through either the physician's desktop computer or the patient interactive computers and chooses an optimization protocol from the available menu of the protocols. The patient interactive computer is then left in the hands of the patient for a fully automated session for the chosen optimization protocol.

A typical stimulation session involves a repeated cycle through the following steps: 1. Patient interactive computer automatically sets implant stimulation parameters; 2. Patient adjusts amplitude to meet one or more predefined criteria thresholds; 3. Patient draws area of stimulation coverage on a body outline; 4. Patient rates effectiveness of the setting on a 100 mm scale; 5. Patient interactive computer turns off stimulation and waits for stimulation sensation to clear; 6. Process proceeds again with a new stimulation setting until the session is finished.

The menu of optimization protocols referred to as testing/procedures before the data analysis may include the following operations in a predetermined combination thereof for a specific testing procedure: 1. A patient controlled amplitude adjustment procedure allowing the patient to adjust stimulation level to meet amplitude threshold; 2. Entry of an area of the pain experienced overlapped with an image of a human's body displayed on the display of the patient interactive computer; 3. Entry of a topography of paresthesias in response to the electrical stimulation overlapped with the image of the human's body displayed on the display of the patient interactive computer; 4. Entry of data corresponding to a degree of overlapping of the area of the pain experienced and the topography of paresthesias; 5. Establishing a pause between switching from one protocol to another; 6. Determination of `multiple thresholds`.

For example, a bilateral optimization protocol would include collecting data from amplitude adjustment procedure (operation #1), collecting drawings (operations #2-4), collecting data related to patient ratings for the bilateral threshold with stimulation parameter selected in some particular fashion (operation #6). In some cases, the software allows a multi-level body-region entry by sequentially entering previous and successive measures of identical nature with reference to the image of the body displayed on the display of the patient interactive computer with the body-regions previously drawn displayed for the reference.

Preferably, when data entered fails to be consistent with expected or estimated data the patient is requested to redo the entry procedure.

Data collected for each stimulation setting is compared against data for other settings and against the previously entered pain drawing. A list of best settings is produced and sorted in rank order by the physician chosen criteria. The best settings may be printed in report format or they may be programmed automatically into an advanced patient stimulator as "presets", which present stimulation prescriptions that the patient may select electronically (the selection of a "pre-set" may be done even if the patient is not in the clinician's office).

The collected data may be transferred between many patient interactive computers. The data may be re-analyzed or used as the basis for further patient testing on other patient interactive computers, or it may be simply stored in a common data base for the center. Patient data and implant information can be transferred to remote data servers.

These and other novel features and advantages of this invention will be fully understood from the following Detailed Description and the accompanying Drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a scheme for neurological stimulation as is well-known in the prior art;

FIG. 2 illustrates the hardware of the computer controlled neurological stimulation system of the prior art;

FIG. 3 illustrates a hardware for a patient interactive system for controlling neurostimulation of the present invention;

FIG. 4A is a block diagram of the patient interactive system for controlling neurostimulation of the present invention;

FIG. 4B is a block diagram of an alternative embodiment of the system of the present invention;

FIG. 5 is a block diagram of the universal transmitter interface unit for generating arbitrary waveforms and programming codes for communicating with implantable devices;

FIG. 6 is a block diagram of a direct digital synthesizer;

FIGS. 7A and 7B show body drawing screens, with the screen shown in FIG. 7B displaying the prototype neurostimulation system, and the screen shown in FIG. 7B is built using a Windows style control and text preferred for a commercial version;

FIGS. 8A and 8B illustrate an amplitude adjustment screen with the screen shown in FIG. 8A drawn from the prototype neurostimulation system, while the screen shown in FIG. 8B is built using the Windows style control and text preferred for a commercial version;

FIGS. 9A and 9B illustrate a subjective rating screen, with the screen shown in FIG. 9A drawn from prototype neurostimulation system (NSS), while the screen shown in FIG. 9B built using the Windows style controls and text preferred for a commercial version;

FIGS. 10A and 10B illustrate a message screen, with the screen shown in FIG. 10A drawn from prototype NSS while the screen shown in FIG. 10B is built using the Windows style controls and text preferred for a commercial version;

FIG. 11 illustrates a question screen drawn from NSS;

FIG. 12 is a flow chart diagram of a patient interaction procedure;

FIGS. 13A-13D represent a flow chart diagram of the stimulation setting test procedure algorithm;

FIGS. 14A-14B represent a flow chart diagram of the threshold task procedure algorithm;

FIG. 15 is a block diagram of the universal transmitter interface unit in alternative embodiment thereof;

FIG. 16 shows a schematic of a tuned tank circuit for generating an RF field for driving the antenna;

FIG. 16A is a diagram showing an output across RF coil of FIG. 16;

FIG. 17 is a schematic of an H-bridge circuit for generating an RF field for driving the antenna;

FIG. 18 is an alternative H-bridge circuit for generating an RF field for driving the antenna;

FIG. 19 is another alternative implementation of an H-bridge circuit for driving the antenna;

FIG. 20 is a block diagram of the driving unit for generating gating pulses for driving transistor circuits of FIGS. 16-19;

FIG. 21 is a block diagram of an alternative embodiment of the driving circuit for generating gating pulses for driving transistor circuits of FIGS. 16-19;

FIG. 22 is a simplified block diagram of a technique for modulation of the carrier signal;

FIG. 23 is a more comprehensive block diagram of the combined analog and digital techniques for modulation of the carrier signal; and,

FIG. 24 shows an electrical diagram of a balance modulator used in circuits shown in FIGS. 22 and 23.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIG. 3, a patient interactive system 24 of the present invention provides a computer controlled system for automatic adjustment of neurostimulation implants used in pain therapy and in treating neurological dysfunctions. The system 24 includes a patient interactive computer 25, which is preferably a pentop tablet computer, a transmitter interface unit 26 embedded either within the patient interactive computer 25 (as shown in FIG. 4A) or in antenna 27 (as shown in FIG. 4B). The antenna 27 is coupled to the transmitter interface unit 26 embedded in the computer 25 through a communication channel which may be a PCMCIA bus 28. This serves t